Lupin 在美国推出 Raltegravir 片剂 USP 600 mg
Lupin Launches Raltegravir Tablets, USP, 600 mg in the United States
Lupin 在美国推出 Raltegravir 片剂 USP 600 mg，该仿制药获美国 FDA 简略新药申请批准，与原研 Isentress HD 片剂 600 mg 生物等效。
As the First-To-File, Lupin is Eligible for 180-Day Generic Exclusivity
, /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced the launch of Raltegravir Tablets USP, 600 mg in the United States following the approval from the U.S. FDA for its Abbreviated New Drug Application.
Raltegravir Tablets, 600 mg are bioequivalent to the reference listed drug (RLD) Isentress® HD Tablets, 600 mg of Merck Sharp & Dohme, LLC. and indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adult patients and in pediatric patients weighing at least 40 kg. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity.
Raltegravir Tablets USP, 600 mg (RLD Isentress® HD) had an estimated annual sale of USD 26 million in the U.S. (IQVIA MAT September 2026).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company's business strategy.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
*Safe Harbor Statement
Isentress® and Isentress® HD are registered trademarks of Merck Sharp & Dohme LLC.
SOURCE Lupin Pharmaceuticals, Inc.
来源：PR Newswire Health · prnewswire.com